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Us 36, Fda 27, Massachusetts 21, Necc 18, Colorado 11, Hamburg 9, Mti 6, Washington 5, Dr. Smith 5, Druce 4, Mr. Dingell 4, Aig 4, Mr. Griffin 3, Michigan 3, Mr. Waxman 3, England 3, Joyce Lovelace 3, U.s. 2, Hank Paulson 2, Mitch Mcconnell 2,
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  CSPAN    Capital News Today    News/Business. News.  

    November 14, 2012
    11:00 - 2:00am EST  

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claim? >> your question speaks directly to why we do need legislation and new authorities. compounding pharmacies are not required -- >> i'm not worried about compounding. ..
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and still do one prescription per patient. one of the things we have done since this is all come to light is to a remind all pharmacies in massachusetts and remind hospitals getting products that it needs to be one prescription per patient for exactly the reasons we have discussed. >> i appreciate it a mr. chairman i know my time is up and i appreciate this hearing being held. earlier today somebody said there would be more hearings and i certainly hope there aren't a hope we can get some answers and why and what we need to do not on the compounding site to make sure the fda has authority because apparently they don't and just to check and see if we have people who are committing fraud claiming to be a compound or when in fact they are manufactures. >> i think the gentleman and all members we are going to go for a second round and i talked to the ranking member and she has
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agreed. it's not necessarily going to be the full five minutes but if the panel will be patient with this, there are no votes today so we have this unique opportunity to have a second round. i want to continue with a little bit of what mr. griffith indicated. he sort of indicated going forward today, have you come up with procedures and interpretations so that they manufactures that are out there doing the same thing as necc that you can stop them? and i didn't seem to get a clear answer so what insurance do we have the public and the legislators that the fda will prevent this from happening today because we might not get legislation. this is a lame-duck session, but the republicans control the house and the democrats the senate. it's going to be difficult to get legislation through normally even though this is a very serious problem and i think we are all bipartisan on this. sometimes it takes a while so
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but what assurance can you give the public that the other necc's that are out there that you're going to stop them? >> i do want to underscore that i believe that we need legislation. >> i might to have more legislation. >> in the interim we are working very hard, working with our colleagues and i mention that we are actively engaging with the state in order to both provide our best possible information about best practices. >> do you feel confident you could stop another necc with a jurisdiction in understanding a half now, could you stop another necc who is manufacturing drugs? >> the necc was not the first and it will not be the last. until we work together to clarify -- >> doctors matthew indicated in your opening statement that because of what is happening people have been fired or
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suspended. is that true? you have also implemented new regulations and new oversight interpretation so that you can prevent this from happening again. is that correct? >> yes. >> dr. hamburg have you fired or suspended anybody at the necc because of this tragedy? yes or no? >> no. >> okay have you gone through introspectively and looked at the agency and said these are the things we need to do to prevent another necc? >> we have done that. we have been working very hard to identify what are the authorities that we need to be able to protect the american people and to help to ensure that they get the quality drugs that they deserved. >> he is it your position today that this could have been prevented by the massachusetts department of public health? yes or no? >> i believe that we need a stronger --
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different actions might've been taken with necc. i wish that that's where so, but i think we have to look at the record. >> did someone tell you to filibuster us? >> i apologize but it's an important issue and i care about a. >> you did not have the authority to stop this. that is what you keep saying today that you don't have the authority to do it. do you think dr. smith's agency should have stopped its? if you don't doubt, just say you don't know. >> i think that clearly massachusetts is working very hard. >> do you think they could have stopped at? >> they were unsuccessful and you know it was tragic. we worked hard with them to limit -- >> okay, okay. i have two more questions for you then. is your position today that the necc was not a manufacturing
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pharmacy and that you had no jurisdiction over its business activities quit is that your position today? yes or no? >> necc is registered as a compounding pharmacy. >> in your opinion, your opinion, this is at the request of the hearing now, is it your position as necc was not a manufacturing pharmacy and you had no jurisdiction over its activities? yes or no? >> that is in subject of an ongoing investigation. >> you have been telling us all day today -- >> i cannot characterize that while this criminal investigation is underway. >> is your position day that the fda could not have prevented this tragedy because you did not have jurisdiction? is that what you are telling me today? yes or no? >> we can speculate -- >> you are in charge of the fda and you are the gradient of the fda. basically could you have prevented this tragedy and you're saying you can't because
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you did not have jurisdiction. >> it's very hard to know if anyone actually might have taken could have stopped this terrible tragedy. i wish that i could identify what that would be. >> the fda did nothing wrong in your opinion? >> you know, i'm not -- >> in 2002 when they inspected and found the problems in 2003 when they wrote the letter and said we we are going to shut you down? you don't have any responsibility? >> this is not a forum on what enables us to speak to -- >> you are speaking pretty well. >> i think that you know, what we really want to do together is make sure that this kind of event -- >> that is axiomatic. we all understand that but the question is we are trying to understand how this can be prevented and you are saying you don't know how it could've been prevented.
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you haven't fired anybody and you have been suspended anybody and it's not even clear that you have initiated anything. we are leaving with the impression that thank goodness dr. smith stepped up to the plate and did something and we are just a little unsure what you are doing. we are waiting as mr. dingell said, we are waiting and we didn't even get assurance when you're asked by the chairman and by dr. dingell, mr. dingell that we are going to get this information. there so much that we have asked for that your agency has not given us. we need the insurance that you will provide it. okay, my time has expired. >> i am pulling myself together. i'm going to ask a question. dr. hamburg i think you can
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agree with me that between 2002 and 2006, the fda made some attempts to investigate this and they were pretty inconclusive, correct? yes or no? yes or no? >> i apologize. >> okay you were not going to answer that. >> in april of 2002, the fda began an inspection of the new england compounding company, correct? yes or no. >> yes. >> and that inspection continued throughout the fall and winter of 2002 in 2003, correct? >> correct. >> now eventually, you weren't there. this was not your job to defend what they did, but in 2002, the fda investigators concluded
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after a lot of investigation that there were jurisdictional issues. is that correct, yes or no? >> that is correct. >> they then -- there was still an investigation but for the most part they turned this investigator over to massachusetts, yes or no? >> yes. >> so what happened at that point was the fda did have some involvement but it was primarily massachusetts. is that right? >> that is correct. >> in the meantime, you know i will say we are just trying to get answers here because we do need to figure out how to prevent this. if we can prevent this kind of thing then shame on us because this is a company that had black specks floating in their files. it had cleanliness that wouldn't even be accepted anywhere in the world and we are sitting here bringing our hands.
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we have to figure out how to give you the jurisdiction to figure out what you need to do and figure out how to give dr. smith and the other state regulators like colorado the ability to work with you to do that, okay? and these inconclusive answers are not helping us. now, section 503 of the act has all of these requirements regarding the compound or's, correct. >> correct. >> compounded drug is exempt from variety of requirements of the federal food drug and cosmetic act relating to drugs for fda's preapproval with the drug is compounded for an individual patient based on the unsolicited receipt of a valid prescription, correct? >> correct. >> and it says the drug is compounded by license compounding pharmacy, correct? >> correct. >> so what has happened overall these years of these drug
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compound ers have started this great big manufacturing facility and then they have the illusion that they are keeping these scripts for the individual patient but they are really not doing that. is that correct? that is part of the problem, right? >> that is. >> now just hold on. the other thing that has happened section 503a says, section 503a says that the fda can take jurisdiction if these compounding pharmacies are exporting more than 5% of their drugs to other states, correct? it says that, right? >> yes. >> what mr. griffin is saying then, why doesn't the fda import that but there is the problem mr. griffin and this is what commissioner hamburg is trying to say. the ninth circuit has thrown out
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all of 503 and it says it doesn't even apply and the fifth circuit has 503a only applies to advertisers and that is what that map is about. what dr. hamburg is trying to say is you know we can point fingers and we can be upset in everything and we should be about what happened 10 years ago and why this operation wasn't shut down by what we really need to think about is what are we going to do going forward to make sure that the jurisdiction is clarified and i would bet you if we could all sit down and talk about a week could agree on the same principles. we don't want the fda having jurisdiction over the doctor and the little mom-and-pop pharmacy trying to make -- but it really is a big manufacturing operation even though it gets a compounding pharmacy. if the laws and clarified now, if there is litigation, there's a separation of court decisions
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in this states we need to fix that and that is our job is congress. so i guess i would say doc or hamburg, you know, i interest and what you are saying but within the purview of the law as it reads now the fda needs to do everything it can to make sure that it presents -- prevents this and furthermore we have a job, we have a job as congress did not try to move the -- around on the titanic. we have a job to clarify the law if there is not clarity and alum and we can easily do it. so thank you mr. chairman and i yield back. >> i think we have a little time here. you and i could have a colloquy here because you can purchase a paid in this colloquy. you are an attorney and i appreciate what you are saying but i think the interpretation of what you did on the spring court is not fully explained as you said. i'm asking staff, did the
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supreme court throughout the entire -- but was it? they throughout only that portion that dealt with marketing and so for you to say they throughout the whole thing so that the commissioner of the fda had no interpretation -- >> no, no, that's not what i said. >> the legal problem is the supreme court only did a small portion of that and left intact the idea that the company that is manufacturing still can be determined if they are a small pharmaceutical or a manufacturer. >> mr. chairman if you would like to have a colloquy -- what i said was -- >> i think you'll appreciate what i said. >> the fifth circuit throughout the 503a provision only on advertising and left the rest of it intact. the ninth circuit throughout all of 503 and then the supreme court took served on the fifth circuit case and on the ninth
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circuit case but they only talked about the advertising. so now it's really a big mass. >> and i agree. because of the fifth of the ninth circuit in the supreme court but i don't think in this is what you are implying, that it creates such a position that the fda had their hands tied and they couldn't determine what is the manufacturing and what is a small pharmaceutical. >> again you are misinterpreting what i said. what i said as there is lack of clarity in the law and what that means is that evildoers like this compounding pharmacies don't feel like they have to listen to the fda and they don't feel like they have to produce the documents when they are requested and they sue whenever his -- and that's the problem. it ties the fda's hands when they're trying to take enforcement actions against these folks even if they want to. >> you are welcome to step in but i think -- i gave her the time and shielded
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back and i asked her if i could have a colloquy with her which she agreed to in your welcome to join in. i think this is a legal interpretation which i think you are welcome to join in. >> mr. chairman i wouldn't want to interrupt your discussion but we do have members on both sides of the aisle. >> oh, sure. i would be glad to recognize you and give you 15 seconds. >> you are right and i'm going to take 15 seconds to just say as the purview of the chairman, think what ms. degette is talking about between the fifth and ninth circuit in supreme court -- i know but i'm determined and what i think is there is still left the integrity of the loss of the fda could determine who was manufacturing and who they had jurisdiction over. with that i will recognize the gentlelady from tennessee. >> thank you mr. chairman and i have just a couple of questions. you all have stayed with us and
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we do appreciate this. a point of clarification, dr. hamburg, you mentioned earlier there are 7500 advanced compounding pharmacists and 3000 -- >> that was information given to us by the international association of compounding pharmacies. >> that is what i wanted to know. >> they are not required to actually report to us so we don't know numbers from our own assessment. >> but you can source that for us? would you provide that sourcing so that we have that? >> okay, certainly. >> thank you. i appreciate that. i want to go back to this issue that you all had because you have the colorado complaint against necc in may of 2011. is that correct? >> that is correct.
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>> okay. and that complaint came into in to you well in advance. any of these contaminated lots being shipped. is that also correct? >> as i understand that it was a request for information from us about whether they were registered as a manufacture, a drug manufacturer and necc is listed as a compound or. >> i think colorado notifies the same fda compliance officers who had inspected and necc in the past. is that correct? these inspectors wear out where of necc's past violations? >> i believe the e-mail was shared within the fda because of the history with necc.
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>> okay and then in that e-mail, did they not say that necc was again shipping volumes of drugs without a prescription? >> with the indicated to us was that they were concerned that necc was operating in violation of colorado state order pharmacy licensure registration laws and they included the volume of product that was being shipped to. >> but it was clear that it was a violation. is that correct? >> what was clear was there were not specific safety and quality concerns, but they were noting that there were not valid prescriptions for. >> then let me ask you this. did the fda do anything at all with that complaint? >> well, we suggested that they
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follow up with the board of pharmacies. >> you suggested it. you did not require? did you even pick up the telephone and called the massachusetts board of pharmacies and say, we think we have a repeat offender? >> i understand what you're getting at there -- >> yes or no, did anybody pick up the phone and call? >> any mail was being used. it was through the colorado -- >> would you like to supply all of those e-mails for us for the record? >> i believe that you have them. >> okay, we have all of those in total? twin did you personally become aware of the situation? i mean at what point in the process to chew individually, not your staff but you -- >> the first cluster of meningitis cases and the
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possible link to necc was identified. >> lets me ask you with my last minute, did the fda ever contact you? >> just so i understand, do you mean in the past or the current outbreak? >> lets go back to the colorado complaint. did you ever get a phonecall or an e-mail from anybody that said we think we have a repeat offender out here? >> i can't speak to the phonecall but the e-mail did not suggest we had any information. >> they knew they had a repeat offender but they did not call you. with the board of pharmacies, like colorado, is there any direct contact there? so many of our state boards who do a great job of regulating the areas contact and work with other state towards who have
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likes supervision in their state. >> we did receive information from colorado about the action but it wasn't until july of 2012 and i wasn't aware of that until we discovered that in the process of producing the documents for this committee. >> okay and let me ask you this. personnel reaction in response to the necc. have you taken any actions they are? >> yes, the executive director at the time has been let go from the department and the board counsel has been put on administrative leave as was the division director for that area. >> are you reviewing your processes and best practices? >> regarding personnel actions? yes. we have reviewed the information and presented it for this committee. we have identified lapses in judgment which have resulted in these personnel actions. >> thank you and i yield back.
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>> the gentleman from california mr. waxman is recognized for five minutes. >> thank you mr. chairman. i find this hearing amazing because what we need to do is to work together to solve a problem and make sure it will never happen again. instead what i hear from my republican colleagues is they want to prosecute the director of the food and drug administration. did she know this? what actions did she take? it sounds like massachusetts has a lot to be apologetic about. isn't that a fair statement dr. smith? >> yes, you are right. >> the question is did fda failed to do things they should have done? well, it sounds like you could have done more. the fda as an institution could do more in the first time they wrote the letter was 2006 saying that this company seemed to be out of control. and then they didn't do anything after that. i have a feeling dock or sublike you are being picked on because
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you are part of the obama administration and republicans have been picking on obama for four years. usually their mantra goes, jobs -- job pastoring regulation. lead industry police itself and we don't want the government involved. now they are saying we want more government involved. and i think they are right. we want appropriate government involvement to stop these things from happening. so you would think that our application would be to get out -- i respect chairman grayson but i have never understood them to be a great legal scholar. seems to me there is ambiguity and if there is an ambiguity it's our job to clear that. you think the ambiguity because the law we drafted him 1977 said one thing and if we want to make sure -- we have to make sure
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that you have all the ability appropriate to act. the courts have thrown out part of that 1997 law. the courts themselves are divided on whether section 503a continues to have any legal force in the western states and five 3a is not affected as well as texas louisiana and mississippi it is and is the map put together put together by the compounding industry itself shows there's a large gray area in between. so why are we looking for anybody to blame other than a company and making sure that the regulators have all the power that they need. that involves my colleague regulatory power to act. it also involves regulators to do your action, to take action to stop these bad actors from doing what they want. i understand the chairman of the
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oversight committee said, we are not going to do any legislation. i would rather do it now before he leaves because he is so involved with this whole question. he should want to work with us to solve this problem. it doesn't sound like it's that difficult a problem. we need the authority to do this, to just this and to do that. if i asked for a commitment to make staff available to us this week if we started the process -- >> absolutely. we are so eager to work with you because we feel there are significant gaps in our authority that limit and undermine our ability to do all that we want to do to protect the health and safety of the american people. you know, i think the fact that we have a situation that matt prefilled suggest we don't have a comprehensive, integrated
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legal framework for action and we think that we can work with you to identify critical areas from registration so we know who is out there and what they are doing, to developing federal standards that should be it here to to ensure safe and high-quality products, the ability to do full inspections. >> i don't want to take you off as completely. i think you need a lot to be clarified that if i were sitting in your shoes, and that is a fixed metaphor. if i was sitting in your seat and i was the head of the fda and i heard colorado was concerned about the situation and heard other reports i would have assumed, i would have assumed jurisdiction. i would have acted on it. and i have to say as a state, people want to make partisan comments in some of what is going on is a little partisan. when the fda first sent a
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letter, it was the fda under the push of administration. in the state of massachusetts had a weak consent agreement it was under governor romney's administration. here now, here is deval patrick and under president obama, let's put partisanship aside. let's make sure you have the authority and the resources to do the job. we want eugene the job because we ought to be mindful of the comments that ms. lovelace made and all the other people waiting to see if they are going to die from this contaminated drug. we don't want excuses but we don't want to leave this law on big u.s. because you are always sued if you act and if you assume you have the authority when you don't your call before the committee to save how could you have authority when congress didn't give it to you? i think we have to put our
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partisanship aside, the election is over, figure out a clear law for the federal government to be able to act because with all due respect, this is not a state issue of drugs being shipped around the country. thank you mr. chairman. >> sure and i will be the first of recognized the chairman of the fda. >> you might not want that job. >> the dr. burgess you are recognized. >> thank you mr. chairman and something that was very important and i don't want to get lost in the translation. representative blackburn asked about e-mails between the fda regional office and the massachusetts board of pharmacy and mr. chairman may i suggest those e-mails are a critical part of our investigation and we must receive those. is it necessary to submit subpoena authority. >> if the gentleman with the. we have gotten out e-mails from the fta. the crux of this hearing is to
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get to the bottom up what happened and we can't get to the bottom if we don't have the information so you're exactly right. the fda has got to cooperate and give us the e-mails but we have gotten zero. >> the ox is to the opinion of your experts would be important to us in this investigation said the entrenches sense that chairman upton referenced in his opening statement is something that really must be overcome. i am of the opinion that you have had all the authority that you needed and yes it was a previous commissioner and the previous administration so once again i would also ask that if there is a memo from general counsel at fda to the then commissioner about you don't have the authority to do what you said you were going to do with this enforcement letter, i think the committee really should see that as well and again, i think we should exercise every power that we have in order to get that. the reason it's important is, if
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if the legislation is indeed passed and passed hurriedly as has been recommended before the end of the year and yet you were not going to act on that authority than we are going to be right back here in the same suit with the same problem some point in the future. it may be a different commissioner from the fda and they will say well there's ambiguity but there is no ambiguity. you have a criminal investigation going on against necc. is that not correct? so where's the ambiguity? if you have a criminal investigation, if you had all the guys at fda taking computers out of the compounder, where's the ambiguity? >> first let me say we are working to get you the e-mails that you want. we have been trying to development.them is to get them to you as swiftly as we can in light of everything that is going on. i know it's not the end so that
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you want to hear, but i do think that there is clearly ambiguity and -- >> a criminal investigation. they did it on tv so everybody could see. >> thinking more broadly about the legislation, you know, i want to do everything to work with you and get you the information that you need. but i think we also do need to look forward and look at where the are the gaps in authority clinics i cannot speak to what was going on in the fta during that period because as was noted i wasn't there. as i understand it, there were very intense discussions and complex about what were our authorities, this ongoing litigation, what basis would we use four different regulatory actions that might be taken?
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>> so help us here. if we are going to craft legislation rapidly before the end of the year as has been suggested several times on the other side of the dies, how do we keep from making the same mistakes again? luck, you have the authority to conduct an investigation as to whether or not you have jurisdiction to conduct an investigation because that is what i have been hearing all day. >> we have authority that consistently contested that resulted in split court decisions in a patchwork of regulatory legal oversight and you know that as part of what i think we can and should address together. >> love, people are dead, doctors have administered medications that they thought was safe and they have to live with those consequences. we heard about the case where the doctors in the intensive care unit and vanderbilt hospital didn't have a clue as to what was really the culprit
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in that gentleman's illness. there is a lot of stuff here that, if there is a problem with the existing statute that needs to be corrected, you owe is the ability to look at those internal documents. time and again, we have to do this before the end of the year. give us the staff. mr. chairman i'm going to ask that we subpoena the stuff we need and do that forthwith. guess i know it's a holiday season and nobody wants to be working on the stuff but we have got to do it. and if we rapidly produce legislation so that we can just say we have done something before the end of the year, so we can all feel good about ourselves, we are going to be back here in the same mess, two years, three years, four years, fill in the blank. what is to stop pfizer tomorrow from saying i'm a compounding
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pharmacy and you can stop me because the fifth circuit of the ninth circuit says you can't stop me. no one believes that is the way it should be and surely you don't either. >> i do not and that is why i do feel that this is an extraordinary opportunity for us to fix some of these problems that have really been present now for at least 15 years and have tragically resulted in incidents involving death, loss of vision and other injuries in harm but drugs that the patients thought would help them and not harm them. i think we can strengthen -- >> you are was the information. you have experts in your control and if this is something that has been discussed internally and there has been a conflict internally, let us be privy to that information so that when we try to craft the legislation
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it's not an imperfect product. we got all the authority we need today to shut this place down and lock them up and send them away for as long as anyone care to think and for writer for reason it didn't happen. >> the gentleman's time has expired. >> ideal that. >> the before i recognized mr. dingell, dr. hamburg we have thousands of e-mails from dr. smith agencies of the fact that you have gotten none she has less resources that they have complied to give us information so i urge you and your staff to comply. >> mr. dingell is recognized for five minutes. >> the thank you. dr. smith and commissioner is it possible for the the two of you to execute memorandums of understanding to find your respective jurisdiction, is it not? is there any reason why you could not or would not devote your attention to achieving such
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a memorandum of understanding so that you can define where the authorities of the food and drug lie and the authorities in the state of massachusetts like? are you going to undertake that, ladies? >> i certainly think their multiple opportunities for us to do better in terms of medication that sort of thing. >> i think you can sense from the committee, questions towards a legislative solution and it may daree well be that we have to do so and i think we are determined to do so. what i'm hoping is that while we are doing that, that you will convince -- commence doing what you have the capacity to do i.e. a memorandum of understanding to define your respective responsibilities so that we can get ahead of this curve and if we cannot complete our business by year-end because of the senate and other things that we are able therefore because of your labors to
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commence the process of moving along on a parallel track. are you willing to do that? >> we are certainly willing to do that and we are pulling together all of the -- in order to clarify -- >> i want to look at how we resolve the problems. >> i have to underscore that is still one address the different regulatory requirements. >> it is most uncharitable. give me an answer and what you can do to get a memorandum of understanding between your two agencies and/or other agencies. now it is possible to define a compounder as a person who makes certain amounts and to define a manufacture as a person who makes certain amounts of pharmaceuticals, does it not?
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yes or no? >> you can decide to put that in legislation. currently that does not exist in the legislation. >> so you're telling me you don't have the authority to do that? you do or you don't have authority? >> in and of itself it is not positive. it could be put into legislation legislation -- >> the new england compounding center and other like -- have engaged in the practice of using a fine loophole of which they are able to ensure that they are able to engage and practices that are at danger to the american people. now having said that, i would like to have you tell me one more thing if you would please doctor. you have one of the required
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treatments for this particular fungicide of -- fungicide of medication that takes places to have availability of a substance called -- there is a great concern on the part of the hospital in my district, st. joseph at ann arbor and they are troubled that there is going to be a shortage of this particular pharmaceutical available to them to provide the necessary treatment for their patients who have been hurt by this particular pharmacy, particular injectable we are talking about today. what is there that we can do to assure that there is an adequate current and future supply chain
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for oral for con is all. >> for con uzoh has been used in the treatment and from the very beginning we have been looking at the possibility of shortages. they did not feel it was a shortage and i have not heard anything further. i will get back to you if there are concerns but i do not leave there is a shortage at the present time. >> this is a matter of concern and i would suspect my people at st. jo's are concerned that you will have hospitals and practitioners elsewhere in the country who will have the same concerned. >> we have been examining that. >> mr. chairman i thank you for your courtesy. >> mr. chairman this is a first for me in the time that i have served on this committee committee today graywith
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mr. waxman when he said that he would have maybe assumes in those areas that are great that they had the authority so i would just point that out to you and maybe it's because i was a criminal defense attorney in my prayer life but the threat that someone might sue me would not stop me from doing my job and if i thought i was right i would have gone forward and that is why we want to see the e-mails and the memorandums and he offered all these questions and ms. degette did a nice summation in the way she would it would have been named as clear and your answers as she is but having been a criminal defense attorney and heard you all day say that you didn't have authority over your authority was there or you needed clarification i have to us the question, what is your legal basis for the fda going in and doing a criminal investigation in this case? >> of course that is being done with the department of justice, but the food drug and cosmetic
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act obviously is the basis for so much of our regulatory actions but the problem here is that the component of five 3a -- 503a has been questioned in the court and it applies in some areas and doesn't apply in other areas and we have compounding pharmacies, we have guidance that we put out that does not have the force of law so you know it is a challenge. >> here is the problem. i fear that in your comments today you may have made the argument for the defense that they will escape criminal sanctions because you have said the law is ambiguous and that you don't have the authority to go forward and i think that is a mistake because look, as i said
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before when we have 1400 or 1500 patients in my area alone i think they are manufacture and just because they call themselves a compounder does not make it so. i could call myself the duke of oral and claimed diplomatic immunity. if you you have been aggressive on this they would have found they were not a compounder a long time ago which is why as you move forward and you didn't answer the question earlier so i'm assuming that you don't routinely contact medical professionals and ask them where they are getting their drugs from so that you could identify and that is what you should have been doing. i think you ought to look at sent -- doing something like that in the future and what mr. waxman said he should've assumed to have the authority when you had a bad actor and i think as you go forward you have to look at that. dr. smith i hope you all would look -- i believe they have may have
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undermined a criminal case today so since they said it was a states responsibility perhaps there's a state law that you could look into and ask your attorney general to look to see if there is any criminal prosecution under the state law because the fda does not have the authority to deal with them from our regulatory standpoint and i'm not sure they have the authority to seize the computers and and do what they are doing. that being said i would now yield my time to the gentlewoman, congresswoman. >> thank you. i appreciate that and dr. hamburg i want to go back to this issue with the e-mails that pertain to necc. the first violation came up in two and please understand that it was unclear in your answer to me about the e-mail. you seem to indicate that you thought we had your e-mails. we do not select me be very clear, we want to do this entire file going back to go to.
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we want all of those e-mails and we want the conversation that took place via e-mail with massachusetts board of pharmacy. i have 81 tennesseans and 13 deaths. we are very concerned about this. we are concerned about everyone that has been adversely impacted. our sympathies and thoughts are with them and we are incredibly concerned about the ineffectiveness of the bureaucracy, and it doesn't matter which administration. it is the lack of attention by this agency to a situation that has gotten out of hand. so just to be certain, do you understand what we are asking? all of the e-mails. we are not in possession of this and we have asked for this. so we do ask that you comply quickly so that we can see the full extent to your
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participation and the manner in which you all communicated with responding both on intra-agency and then also with the massachusetts florida pharmacy. with that i will yield back the balance of my time. >> the gentlelady gives time and the gentleman from massachusetts is recognized for five minutes. >> thank you sister chairman very much. dr. hamburg is not true that the legal definition of druggy manufacture in section 510 of the food drug and cosmetic act exists -- -- exempts pharmacies? >> you know, i am not a lawyer but my understanding is yes. >> that creates a problem right up front from a legal perspective. that clear statement that exempts pharmacies from fda jurisdiction of and when it
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comes to drug manufacturers. in the actual definition itself, it kind of talks about what is the equivalent of merck or pfizer and explicitly says pharmacies are not governed in that definition. so that is just loaded with a potential for lawsuits, for questions that can be raised about your authority and do you need that clarified so that you absolutely have the ability to regulate compounding pharmacies in a way that protects the public health and safety? >> i think that exempt from registration not any kind of jurisdiction but i think the problem is that we have no
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authority in saying that our authority over drug manufacturing is very different and it requires a set of clear actions on the part of the manufactures and on the part of fda. in this area, it is simply much more murky and it is contested in the courts and and we have a flipped court decision. we have different legal frameworks that govern different states and yet we have an industry that operates across these boundaries. we don't have that kind of authority that we need and we don't have the kind of clarity of the legislation that we need as well. you know, i am deeply troubled by what has happened in this case and with necc and if there were actions that could have been taken at an earlier time to prevent this, i would wish that were so.
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but you know what i'm speaking to now is we have this opportunity and it's a clarion call to action i think in if we don't want to see that kind of event repeated, and it's not an event that has occurred in isolation. there have been a fence and so many member districts in the past over a period of many years, that i think we have an obligation to work together, to create new legislation that lines this in a way that it's clear and understood and that gives the fda new authority. it was mentioned, why are you writing to compounder's but we don't even know the universe of compounder somewhat they are making so we clearly need additional authority in order to achieve some of the goals we have been talking about.
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>> doctor, that is why he listed the individual legislation so it would be clear that you would welcome that authority and then we could ensure that you can be the true cop on the beach. but i do believe it is troublesome that in the legal definition of drug manufacturer, the legal definition in the fda statute it actually exempts us in that definition. the whole area is rife with ambiguity and in that ambiguity we wound up with the mess on our hands. we just have to make sure that never happens again. mr. chairman i think you. >> thank you and i would say to the panel we have completed our questions and is the chairman i have usually the authority to say the last few words. in defense of mr. markey who made the case in his words as murky, go back to what
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mr. waxman said when he was chairman of the fda he would not have been cautious. he would have been citing on safety and had gone through and exercised regardless of what the situation, i agree with him and that is why i probably should consider being the commission chairman and also i would say to you, if pfizer or merck or any large pharmaceutical company suddenly call themselves a compounding company you are implying he would not have jurisdiction over them when we know that's not sure and in fact when you look to start or you see lots of criminals being indicted and they make the case that i was doing work or the fbi undercover and lo and behold that was just a front so that they could defend themselves when actually they were committing fraud and criminal activity. lastly i would conclude mr. griffin and dr. burgess indicated certainly if you have the ability to go in and
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prosecute and take the computers from necc then surely you have the jurisdiction to shut them down because you have the jurisdiction to go in and take their equipment and certainly i think many of us on this committee are disappointed that you are not providing the e-mails and the information we need so we can get to the bottom of this and that was the intention of this whole hearing is to see what really happened. with that, the subcommittee is adjourned. [inaudible conversations]
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by military trainers at the lakeland air force base in texas. this 40 minute briefing in chases 45 policy changes being enacted at lakeland which is the home of all air force basic training. >> good afternoon and thank you for making time to be with us here today. i'm joined by major general woodard who is assigned to air force safety here at the pentagon. ..
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they visited basic military training at san antonio lackwit, for technical training bases. the officer training school at maxwell air force base in alabama. and the u.s. army's basic combat training at fort jackson in south carolina. additionally, the team conferred
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figures responsible for u.s. navy and marine corps basic training. the one to express my deepest appreciation to general woodward and a team for a job extremely well done. the 22 findings and 46 recommendations of the report accurately reflect the deficiencies in her basic military training program to provide effect their proposals. i intend to implement 45 of the 46 recommendations. we distributed copies of the directives investigation as the lesser part i prepared for the secretary of the air force with my review of the corrective measures i'm putting in place. i do not intend to cover is a report in this afternoon as our time is limited and i want to be as responsive as possible to your questions. that said there are a few points i want to make you for opening the floor to you.
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first, when the senior leadership of education and training command became aware of the significant level of misconduct by military command structures were made for commitments. first, to thoroughly investigate all allegations of misconduct. second, care for victims of misconduct. third, to hold perpetrators accountable while protect you and due process those accused and for us, to correct the underlying problems that led to the misconduct. i believe we have made good on each of these for commitments. our investigative process has involved over 280 investigators and support personnel who spent over 40,000 hours conducting interviews, analyzing data and pursuing leads. we are determined to follow every day to its full conclusion and we will not end our
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investigative work until we've achieved that goal. every alleged victim whether of assault or a nonprofessional relationship, every single bit and has been contacted and offers support under the air force's sexual assault provides program and other services are based agencies such as legal assistance. we will continue to provide support to any future victim identified as a result of our investigations. we are also making good on our commitment to hold perpetrators accountable. two daytona five court-martials court-martials have been completed and each has resulted in a conviction. additionally, under article xv of the uniform code of military justice, one is struck to receive punishment for a nonprofessional relationship that does not involve physical touching. additional instruct is a pending charges and others are under
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investigation. this process of accountability will continue in the weeks and months ahead. our final commitment was to fix poker on our basic military training program. the keys to successfully fulfilling our obligations in this area are to not only understand what happened concerning the misconduct, but how it might happen as well. i would like to address the what, how and why questions in the context of what a properly functioning system of maintaining good order and discipline in basic military training should work. because we know the basic military training environment is highly susceptible to the abuse of power, with established institutional safeguards to prevent misconduct by instruct druce. these safeguards are designed to dissuade misconduct very strong as sharp or selection screening and training process and to deter misconduct are an
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effective system of detection and accountability. leaders play a critical role because they must constantly monitor safeguards for weaknesses and make corrections as necessary. moreover, training is struck druce had a responsibility to uphold our core values and hold themselves accountable for helping to detect those who violate our standards. in a properly functioning system that minimizes misconduct, most instructors will be dissuaded from inappropriate behavior and a few who are not will be detected and held accountable for their actions. leadership will have good insight into the effect of miss that the institutional safeguards and the instruct druce will police themselves. returning now to the three questions of what happened in basic literary training and howard why did it happen in simple terms, what happened is that we had a break down in good order and discipline among the
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relatively few, but not insignificant number of our instruct her spirit how this happen is attributable to weaknesses and gaps in the institutional safeguards designed to prevent this type of behavior. why this happened is related to insufficient leadership oversight concerning preventing and detecting gaps and weaknesses and in an adequate level of self policing by our instruct druce. as you read major general woodward's report, you will see findings and recommendations are closely associated with these three areas: institutional safeguards, leadership and infrastructure culture of self accountability. more specifically, 20 cdi recommendations versus the wrist strengthening institutional safeguards. 14 recommendations associated with strengthening leadership and 12 recommendations associated with strengthening
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the mpi culture. what went wrong in basic military training is not a mystery to us. as i indicated earlier, we understand the what, how and why of our deficiencies and because of this understanding, i have confidence solutions we implement will effectively address the root causes of the problems we have identified. while it is imperative that we address today's challenges in basic military training, it is equally important that we put in place stronger mechanisms to prevent these problems from recurring at some point in the future. conditions that led to the abuse of power in basic military training are ever present your desk and the vigilance and engagement must be persistent as well. to that end, i am directing establishment of the military training oversight council, which will be chaired by a three-star general.
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the purpose of the council is to ensure we have the appropriate level of leadership oversight over issues associated with treatment safety and maintenance of good order and discipline. additionally, and maintenance of good order and discipline. additionally, and maintenance of good order and discipline. additionally, with instruct her misconduct are not exclusive to the united states air force. these impact basic training programs of other military services as well. a greater degree of collaboration will strengthen each of our programs and to this end i've directed the commander of second air force to establish a recurring tri-services session counsel with our army and navy counterparts. i'll close by quoting from major general woodward's cdi report. quote, this report necessarily focuses on the few who violated a sacred trust and broke faith with their fellow airmen everywhere. it is important to remember
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despite the extraordinary scrutiny of basic training, honorable men and women throughout the air force enlisted training complex continue to serve every day with distinction. these airmen built our air force one person at a time and remain proud of permission and of themselves. they make a positive contribution and a profound difference every single day. their efforts continue to produce the world's greatest fighting force, unquote. i couldn't agree more and we are committed to doing everything we can to make our basic military training program the worlds finest example of military professionalism. i will not open the floor to your questions. >> is identified a lack of leadership oversight is one of the main problems here.
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who were the leaders involved in that lack of oversight and have they been accountable? what has happened to them? what specifically were the shortcomings? >> one of the basic responsibilities of command especially as the maintenance of good order and discipline in the organizations over which you have command. that is especially true of the squadron commander level, where they have daily interaction with members of the command, and the crew commander has a considerable level of oversight on a daily basis and that the wing commander level. so when we come for command authority at these levels especially, that is where we have to depend and demand the commander's exercise those authorities we've given them to maintain good order and discipline within their units.
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besides what what happens in basic military training and each individual case, i have found areas where commanders did not meet next nations with respect to creating the type of command climate necessary for good order and discipline to be in a healthy state. to date, we have announced release of command of two commanders, one of the squadron commander level, lieutenant colonel peck had been one of the group level who is in charge of the group. we have also -- i have also conferred disciplinary action with six additional commanders. that process is ongoing.
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but the process works is one second further disciplinary action, the commander has the opportunity to provide me with information that he or she might feel that i didn't take into account and then i make a final determination. so because those actions are still underway, i'm not going to publicly talk about names, but numbers we talk at this point of potentially eight commanders. >> what are the possibilities for them? >> i don't look at this in terms of punishment. so i think it is important to clarify what we are doing here. this is a punishment in terms of a court martial or in terms of nonjudicial punishment under article xv. i did not uncover a single case
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where a commander of a symbolic act to blame in behavior that was against rules and regulations. in fact, every single commander we are talking about is a fine officer, keen to work every day, worked very hard to address the issues associated with trading and discipline in this environment. so this isn't about punishing people for wrongdoing. this is holding them accountable for the responsibilities we had conferred on them and it is about reflecting the times when they didn't meet our standards with respect to how they discharge those responsibilities in a way that properly is reflect about their performance during this period of time. so i want to ensure that i underscore that point. this isn't about bad people and it isn't about punishing bad
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people. is holding people accountable for the high standards they must have been this important area of good order and discipline. >> general come you mention 44, 45 recommendations you plan to implement. what was the one you decided to move away from them also going back to your comment about the themselves. can you explain how that's going to work and resolve these leadership issues you are discussing because it's seems to me wasn't that no one was released in the skies as for his actions. so those are the two questions. >> when you ask a lot of questions that makes me forget the first one, [inaudible] >> 46 recommendation had to do with the length of basic military training. so when general woodward and her team came in to do their work, we already had initiative
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underway to look at the length of basic military training. it's a perhaps weeks now. we're looking at potentially reduce enough. she looked at the effort and said if he do that that would be a good idea because would make sure you don't have any what we call white space in the schedule, where students are idle and don't have a lot scheduled this everybody knows gaps in tynecastle this something and sometimes it's not good. she said if you do that that would be a good idea. we are continuing to review the proper length of basic military training. i have not rejected. it's just that we look at it in a different form. i think your second question had to do with the mti's themselves and self policing. and how to make at that. that's a tough challenge. anyone who knows about culture and human behaviors, changing a culture is a difficult thing to
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do. i want to underscore when i talk about culture, i talk in a positive way and not so much in a negative way. what i want and what we must have is a very strict adherence to air force core values come a culture that values professionalism above all else and hold themselves accountable for professionalism. so what is not enough for someone to go to work everyday and do everything they need to do in order to be professional. they've got to be actively looking for fellow airmen and instruct jurors working for the early signs of being impacted by abuse of power, which will happen in this environment for any environment where you have a significant opportunity for that to happen and to take proactive action to own this challenge of ensuring that everyone acts in the most professional way
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possible. so the susceptibility to the abuse of power is well documented not just here, but in any situation of the type. and we believe we can do more to both equip each individual but the warning signals they should be looking out for among their fellow airmen and taking ownership of the responsibility to not just monitor their own behavior, but those around them in a way that once someone does in the standards come in intervene early and report those 70 should be reported to the system. i would say i think part of what i heard she said is that it is obvious this wasn't going on and i don't think that's true. we would not have known what we know today had it not been for military training instructors coming forward and telling us exactly what i just said.
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we have indications are training our standards and we took action on it. so this was occurring. it needs to occur more frequently and at a higher level. >> some people say the air force has a zero tolerance policy when it's any relationship between instructor and trainee partly because the idea that these relationships can be can and should give them power of balance is hard to believe. why is that level of strictness in terms of consequences not appropriate to think? >> it is appropriate in fact it's my policy. >> fumigation this relationship, you're out of the military. >> when we make the statements, might feel having done this for a long time to say something happens in the something else automatically happens, it tends to tie the hands of commanders in the judicial system in the
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way this usually not healthy. so each one of these cases is an individual and unique case with individual facts and circumstances and i believe we have to let people with responsibility and authority and maturity look at each case on its own merits me to judgment about what the appropriate action to take is and give them the tools and flexibility to take action of less severe in certain cases that call for very severe in other cases and we will probably end up with a system that results in mice just as if say every case, regardless of the facts involved fits into a certain box. we are about in the right place now where you have a strict policy that prohibits any kind of personal relationships between a trainer and a student or trainee and it's not just
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some pain you are responsible for nick postern. if anyone who is a trainer, anyone who is a student in the system because i think it is important that we do everything possible to maintain the most professional training and education environment that we can emulate any suspicion of favoritism that might result from personal relationships that might have been. so, thank you. >> the investigation of the cases for supervisors and commanders as to report said insulated from rather than engaged with their squadrons. i wonder how you can explain how a commander becomes insulated from the airmen and their squadron. it seems on the first duties was to be sure they're interacting with people at every level, that they know everyone, even if it is a thousand people.
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>> all that general woodward respond to that. >> thank you, mr. chairman. i would say that we didn't necessarily help them in that there is a single squadron commander as the single officer, the single nonmilitary training there but did not squadron. so very difficult for those commanders to come into the squadron and breaking into that culture if you will be in this the the sole officer of such ideas as far as the time they had available to spend in the squadron with their airmen. so the recommendations of general rice has except it and putting into place very add additional officers into the squadron and additional senior ncos are not necessarily
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military training instructors will help that and create a more normal environment and not squadron and create a better environment for that leadership oversight to take place in the proper way. >> is their main issue if people didn't have time because you put a lot of new people in this process and your proposal missions. >> yes, as i said it is difficult for a single squadron commander, so having additional leadership oversight i think is beneficial. but i also think it is a focus. a culture had developed over time aside from the mti said, hey, we've got this in the squadron commander didn't necessarily want to or need to in some cases, not in all, but
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in some cases break into that at a deeper level and i think that hurt the oversight in some cases. >> let me just follow-up on not because i think it is an important point. whenever you put more than one person together in any sort of an association, they develop a culture unassertive enormous behavior and expectations. that's usually good at lots of positive things come from cultures. but she was so have to be aware of the negative elements other culture developing that can manifest behavior. what we done is to ensure we ain't seen how the elements of the culture while not allowing it to be so insular, so close to outside influences that negative elements develop and go
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undetected. so we put people in place in leadership positions with authority who are not necessarily part of the day-to-day function of the military training instructors in an effort to have the appropriate level of positive elements of a culture that need to access, but not to be so insular that it can't police itself over time. >> general woodward, i apologize i haven't had a chance to breathe your findings have. you mention increasing the number of officers in the squadron. was one of the considerations increase in the number of female officers of female leaders within the squad? >> not specifically female officers, though having good female role models throughout the military training environment we think and we talk about in a very positive and important piece of developing
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the right culture, not just basic, but through our air force. one recommendation we specifically made was to have for each two basic military training sites to have for military training it struck is responsible for those two flights in and of those for mti's, one should always be a female. that would maximize exposure for mail and female trainees to female role models. >> i'm vice versa. this is one of the really strong by coming nations made. the great thing about our air force is people come from all different experiences, walks of life. some people have never been around an authority figure of the opposite and that's the way the air force will work when they had their first unit. they may be under the authority
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of the female or a male only want to make sure they have a full range of that experience and basic military training and this'll make that happen on both sides of the gender line and it's a terrific suggestion and recommendation. >> just one follow-up. are there enough they not mti's? >> now, so now, so what shall see in the report is a hefty bill to that level and above the 45 recommendations, that will be the last one that we complete fully. we party embarked upon that path, but her ability to them and put them through our training program and moreover, i don't want to rant but all at once because then i changed them all at the same time. it's better if i do this on a gradual basis, but very pricey pieces. we'll do that over time in the next year. >> it seems like you're adding a
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lot of sort of extra layers. you've got an additional oversight council now. why is the existing infrastructure you had of oversight structure not sufficient and how they not prioritize this enough in the past? the other thing is, what are you sensing and general woodward may speak to this as well. what are you sensing in terms of the understanding of the mti's and the training, trainers and everybody involved about how serious this issue is indeed feel like there has been a change, or is there just resent vince at the allegations and resentment at the investigation and so forth? >> i'll ask general woodward to
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respond to the second question first and then i respond to the oversight issue. >> as your general rice say in his remarks from our report, we have some incredible, a great number of incredible americans serving at lackland as a military training and struck areas and they are all extraordinarily proud essay should be of what they do and how important their mission is. that's any time you go there. if i can finish -- thank you. they are very proud of what they do and they believe in our air force culture and our air force core values. so they are as horrified by what's taken place by bair fellow mti is as general rice and i and anyone else is.
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the sense i got disappointed is the best word in the fellow mti's does not detract from how important their mission is and how they believe in it. so when you talk about resent and, per se that's not. they want to fix the problem and move on and they take their jobs very seriously and were actually very lucky to air men like that in our air force. >> preference the oversight for the existing mechanisms not sufficient. the nature of this problem, especially in this environment is such that it requires an extraordinary thoughtful of leadership focus and attention. you know, i'm a pilot. i fly airplanes. when you fly an airplane you have to pay attention to things around the cop put so you look
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at this instrument in that instrument into what any instrument to go long without looking at it for the plane will get out of parameters of control. my analogy is that this problem is like your attitude direction indicator. it's her principal instrument that she always go back to actually look at another instrument. so you have to spend more time focusing on this instrument if you want to keep this airplane under control. it takes an extraordinary couple of leadership, attention and overtime because we demand so many things of our leaders, when we bring readers and who have been successful in other environments, but not this environment, the level of focus and needs to be placed on this challenge in this environment is much different than they have experienced another environment. i need to make sure that the
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level of leadership focus and attention we're putting on this now is institutionalized. one of the features of military services, next summer i'm going to have turned over half my commanders. people come in from all sorts of different places who are part of this challenge right now and they need to have been focused on this and i don't want to depend if they just heard about it because it won't work. i've got enough experience to know that. so i need to institutionalize the leadership focus on this and that's why i'm going to have a charter, a regular meeting schedule for the oversight council so that among other things on a changeover over half the leadership team next year, i've got an institutional way to keep them focused on a problem that if you take it out of your crosscheck coming in now, for very long it will get out of
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control. >> is that the underlying issue seemed to be a disproportionate number of problems or behavior coming from the air force training. maybe that's unfair, but these are something specific and air force culture that is problematic and how do you do with the negative aspect of the culture? specifically what are the issues and how do you do with those of the culture? >> know, i don't think that there's anything specific to air force culture and in my view, military culture in general. this is a challenge throughout our society. we hold ourselves to a high standard in the military and the air force says we should. this is a challenge everywhere is no excuse at all for us not to get our arms around this and do better than we have in the
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past. so i think that with respect to the cultural issue, what do we do and how do we get our arms around that? it has to do with both how they selected and screened military training and struck pairs in the first instance and we put an additional recurring process to try to get the most professional people possible to do this duty. it's a part of how we can prepare them for this environment and we put additional rigor into helping them understand the difference of the military training and struck her, were for the first time any of going to have a account level of power and how that can be insidiously impactful to them over time. it comes with not only having that training at the beginning of their training and structure to her, but repeating the
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training over time so one of the importance recommendations that were put in place is what we would call a continuation training program such that we reinforce this overtime because of the way this can work and impact individuals. it comes quite frankly from a realization that some dangerous simple as a first sergeant who's really rules to help the commander with personnel issues, good order and personnel issues raised in the level of fat from a master sergeant to a senior master sergeant, putting a more experienced senior individual in that position to help develop this culture in positive ways over time. so there's not any one single
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piece that's in play. i think it's a good time for me to underscore the fact that this isn't the end. i mean, i don't take these 45 recommendations and think the work is done and we can move onto the next next challenge. this is an ongoing process. one of the reasons i put in place the oversight council is because it is important for us to make a living to continue to improve our understanding of the challenge in the actions and activities and initiatives we need to take to get after the challenge. the cultural piece of this is one that we have to continue to try to understand better and work to work because it's complex, because were talking about human behavior and human feelings. if taken some good initial steps, but we have more work to do in that area.
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>> general, defense lawmakers on capitol hill tracking this issue blinked on the way to solve the problem in the air force and military is through legislation. but the steps he's taken to the investigation and so forth come to think this now since the message to those lawmakers that the problem, understood as a continuing process, but as of now the issue that back when in other areas that's been addressed completely by the air force and there's no need to pursue whatever measures they are looking not. >> i'm very clear that i would in no way try to suggest that congress should or shouldn't do in the oversight role, which is very important and they have an important part to play and i'm sure they will discharge this responsibility is in the way they see fit. i do have a few about whether or
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not commanders and the authorities that i have is a commander are adequate for me to address this issue and make you feel that i do have the authorities in the current legislation to properly deal with these issues. my focus has been no forward would be to ensure that we are holding leaders, commanders accountable for the decisions that they make or don't make given the authorities that they have. and that's why you see me holding commanders responsible for that very thing. i don't need additional authorities are changed authorities. penny to make sure i'm holding people accountable for properly using tools available to them and in my judgment, that would be the more effect way to move forward. >> last question over here, sir. >> h. circumstance dealt individually and consequences are uniform across the board,
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how will trainers know when they truly crossed the line out when they're just going to get a slap on the wrist or something else. >> s. what we pay commanders for. at the end of the day, that's why this idea of commanders responsibility for good order and discipline is so important. at the end of the day, we judge results. you might have five commanders and they might approach this in a very different way, but at the end of the day is a clear signal sent to command of what their limits are, what their expectations are, what their standards are and they need to take aggressive action for kidney every way the individual situation cause for to ensure those expectations are met and when they aren't the people are held appropriately accountable for them. so again, it becomes problematic when you try to legislate too much because you tie a
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commander's hands more than you free them to do with the situation and the way that it needs to be approached. >> i would add that i would say it's very clear, every single of the 215 witnesses we interviewed, there was not a single individual don't know exactly what the atc policy and what their responsibilities as individuals were so the ones that chose to violate that knew they were violating a regulation or policy and that was very clear to them. >> thank you very much.
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>> the fourth annual washington ideas form is happening this
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week. topics include plastic selection of what to expect if president obama prepares for his second term. next, we are from massachusetts congressman, barney frank of the house financial services ranking member. from the museum, this is 20 minutes. >> congressman barney frank in his last term as congressman and enter by sorkin, do they too failed and the dealbreaker column in "the new york times" and on cnbc -- what is there? i watch it every day. and we have half of doctrine care. >> thank you and thank you for being here. there's about a hundred things for us to talk about them it is a very short amount of time. i want to get into issues related to wall street, but given the watercooler conversation seems to always be a blast from the 72 hours, jenna
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petraeus and this -- the real housewives of alabama. under the floor to tell us your thoughts. >> having for a long time argued that my sex life with some of the public's business, i extend the same courtesy to general petraeus and to general alan the notion that you're in trouble for sending flirtatious e-mails is very odd except for one thing and i'm disappointed in both. when i went to work 45 years ago, i was told seriously there something you've got got to remember. you're never write when you can talk. you never talk when you can not and never nod when you can wink. by these two very intelligent man for sending these embarrassing e-mails is absolutely baffling. do they not know -- talk about white collar crime, no one would've been indicted indicted if it hadn't been for e-mails?
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beyond that, i'm sorry for the petraeus family. it does not appear to be any public policy relevant to this and i'm sorry people are fussing over it. >> okay, let's talk about something that is a major public policy issue right now, which is the fiscal cliff. what is about to happen here? >> well, the question is whether there is a recognition on the part of the republicans particularly in the house that they will pay a price for maintaining at least a rationale for what they were doing before the political sense and that if they cause great cause over to the disadvantage of the president. that's no longer the case. the notion that she go ahead with reducing the deficit solely by cutting domestic programs i think is the substantive or politically untenable.
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that doesn't mean the house republicans would insist on it. the other thing is this in the media gets away with a spear president probably did it during the campaign, this notion of let's close some loopholes. people get away with giving us a solution without mentioning a single loophole they plan to close. when you get down to it, though some are controversies at a rate increase. >> putting $1.6 million in revenue on the table, to think that democrats steal or actually have a mandate to get that type of revenue through? when you look at this election -- >> what you're talking about his son during one part of the bush tax cuts, which were adopted after a president got it a rowdy of half a million. if half a million if you're mandate to the tax cuts and commit 3.3 million plus ought to give you a mandate to get them
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out. [applause] >> how much of the president's vote do you think was about taxes and the argument that he made about higher taxes versus all of these other issues including social issues, immigration and other things. >> i would say just as the go clinton having got us to raise taxes come which i proudly voted for, i don't think the tax increases they did under clinton, as i recall, talking about $36 per thousand in income, the notion there were people out there have in the marginal rate going up to $36 per thousand are going to say this is not worth that was disproven then. but i think the tax increases he voted under clinton caused great economic boom, but they didn't prevent it and that is the key. i don't say the president got a lot of votes because he was the driver of rate taxes.
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the relevant fact is republicans to beat them over the head with that backfired. i do think it helped him some, but the fact of its natural end beyond that but a stance for is relevant. that is who is a mandate against severe cuts in domestic spending from a severe cuts in medicare. republicans talk about cap entitlements, but the major argument about medicare was to cut 700 billion come you shouldn't have done that. there is certainly a mandate for avoiding the cut for domestic or brands. there's another piece. they probably did us a favor of advocating significantly increased medicare spending and for the first time since now we don't need that. for better rothermel is also a factor because clearly the substantial reduction has to be a part of the deficit plan. >> is the president and democrats bradley hold the line
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on 39.6% would constitute 50 and above? antitakeover fest on the table? >> holding the line of 39.6 in 250 above does that rollup 39.21300. that's what it came to. >> it's not 35% will find deductions in all of this. >> i think we do hold on not. more popular than not. if the alternative is a reduction package that comes entirely out of domestic spending, i would say this, maybe someone will come up the list of deductions. what are the deductions? oil and gas related? investment related? >> may be charitable giving. >> which of course there's no way that romney threw out during the debate. isaac hrt can say pick a number. is this a lottery or a debate?
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uses 25,000. a $25,000 cap in reductions will be severely impacting middle class people. if you've got march in massachusetts in the first two years ago about about $25,000 on your mortgage interest alone, not to mention health care and everything else. so i'm skeptical. in principle you can talk about cutting the loopholes. i'm skeptical people come up with a list of popular. >> are you believe that the fiscal cliff is that the fiscal cliff and it's a bunny slope, that effectively going over it is not nearly -- >> getting royalties. that $1.18 for an essay about in the "washington post" about the fallacy of metaphors in discussing public policy. i'm serious. last night the domino theory --
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remember in korea it was dangerous because it was poisoned like a dagger at the back of japan. the likelihood someone will pick up korea and start japan with it is sufficiently unlikely pair plus the little eccentricities, why was it the back of japan? but it's neither. it is what it is. if we do not avert it, it will cause a short-term bump to the economy and the question is not whether or not we do it, but how long it lasts. at the sequestration is more damaging than the tax increase, that can be undone. sequestration is a terrible idea and can be very disruptive. if we go into sequestration, that's awful. if the taxes read up on everybody for a month or two, it would be a temporary bump comes falling down the expansion, which is coming, but you can undo it.
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>> i want to talk about dodd-frank and wall street with washington in particular the white house. when you look at the response in the way wall street has approached dodd-frank with the lobbying efforts against it and really the aggressive nature wall street took more broadly terse president obama, how do you explain it when it did about it, when you talk to people? >> we seriously hurt their feelings. last night and serious about it. when you look at the damage done, people ranting about marginal tax increases, which they would not even know happened unless they were particularly attentive to what their accountants told them. and serious, these are people who wouldn't miss for a few bucks out of a passing. i really believe one of the things people want from us, people in the business is psychic and 10. they want very much to be told
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they are good, important to do useful work and are not just self-interested, but in the course of their self-interest -- was substantially hurt their feelings because they're acting i believe irrationally among other things by the way, there are and they may be what do they dodge the bullet. if you look where the republican party is today a new book about wall street wants, do they really want to start ben bernanke from doing what is doing? to the ability of the imf not help in europe? that's the republican party. the republican party is the most right-wing elements, totally in contradiction to what people want. with her feeling so badly -- >> was that a mistake in terms of getting legislation through? >> without the bill passed and president reelected. >> it took a lot. >> what else do i have to do?
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[laughter] >> has the president last? yeah, but i think barack obama is the president. that means in the next four years for the time he's through, the health care bill will be fully implemented and very popular. people will be benefiting and they don't want to see it go away. the financial reform bill would be substantially as it is written. it seemed to contribute to stability. already got people should be maybe it's a good idea but can step in to do into the money market issue. i think the economy is poised after the series of suppression to go forward. so i think the business makes a terrible mistake. first of all, they tell themselves out of the business. i hope they'll turn it around, but i was surprised to retake jim palme d. who ran for president on a democrats terrible platform and headed to
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the financial services roundtable. if i was still the ranking democrat and tim valenti came in when i first requested be the tricks like to make an why my marriage to do so much. i'm a little bit uncertain about that. but secondly, do they expect us to work with people who demonize this? >> what to say to those that say dodd-frank didn't go far enough, that has speechwriting has made the world more dangerous, not less. the list goes on. >> two points. we get attacked from both sides of you which afar, didn't go far enough. too big to fail is wrong. the notion that we didn't, we did see this. there are institutions that are too big to fail without paying attention to the consequences of the failure. best of the bill does. the bill says that in some cases to federal authorities may have to step in and manage
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consequences of the failure, but any dollar expended will be covered from large financial institutions. the secretary of the treasury will file their federal bob and extend money to a big fan. i saw this from the guy from dallas, there will be enormous political pressure on the secretary of the treasury. in what universe? right on america today is even thought of helping an institution they be impeached. i do not understand how people misread. >> you don't believe if jpmorgan or citigroup are really troubled that think they were going down and markets are falling apart under voluntary sahara or would find a way to save that for quick >> is the other way round. he must be disconnected with what's going on in the world. seriously, any effort to help existing financial institution, from the guy who got the point better, debating guy who wrote
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the book who attacks us as well as the economist for preventing intervention at that point. if you're time that congress would then vote to change it, it would take a vote of congress. it would be illegal to do anything with the institution until the institution is spread out. under the law, sarah palin was partly right. we did t-test panels in 2010, but they were for big banks. no aid can go to any institution until it is wiped out. and then you can do with the consequences of it and it may take money to pay a cent. remember, hank paulson says here's my dilemma into custody. i can either pay all the deaths are not of a failed institution. i paid nonpermanent it hit the fan and we paid all that does
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for aig. solicit pay only for those who need to get in trouble. that's what would be controversial. the political imposter be to bailout wells fargo is exactly the opposite. >> how do we judge the bailout? >> is the most highly successful, widely unpopular policy in the history of the country. either way, let's start with the auto industry co. which turned out to play a major role the president winning the election. i was just talking to dave smith. we were doing at the time because it is the right thing to do. who knew it was going to end up being the major thing. with regard to retire, it could've been done better. one thing i would hope political scientist at right about because we missed some opportunity to do more about mortgages, people didn't focus on the fact that t.a.r.p. was basically formulated and put into place during the transition between
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presidencies. the vote in october and then comes the election. and so you had hank paulson operating, but the bush administration had ended. the obama administration hadn't started. i was for a frustrated. i want what the president said, well we only have one president at a time. i said well, that overstates the number residents we now have. last night and that was part of the problem. the money has been paid back substantially. it stabilized the economy and i know it's very popular. by the way, it got worse at a particular point in time. it's when aig got a hundred and $60 billion. >> in part if you really think about it now, aig in all of that. >> yes and blamed for the unpopular t.a.r.p. goes across the board, no question.
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aig, the first $80 billion came from the fed on its own. but when i cannot aig paid the bonuses, i've never seen the public so angry. the answer is that there's a successful policy that could've been better, succeeded what had to be done and ultimately will be seen as having laid the groundwork for a recovery from a near collapse. >> okay, you're not going to be in your job next year or the person who deals with wall street in many ways is maxine waters. it's going to be a bad joke. it's going nowhere fast. let's not go there. what i was going to rescue his face and really have less than a minute left. when you think about washington after you leave, do you have more hope about some type of bipartisan compromise of the world is going to get better here? to have less hope? >> personally, reality is going to get better in reality shakes
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fist. people talk about dysfunctionality. but a functional 2009 in 2010. and in 2007 and 2008, bipartisanship -- when we took over in 2007, had paulson writes in his book he and i have been talking for a couple months. we put fannie and freddie and conservatorship stopped that together with him. we began working on the crisis. in 2008 in september, go beyond not. in late 2007, george bush goes to nancy pelosi and harry reid and says i need a stimulus because the economy is in trouble. unlike mitch mcconnell the center right, let's work one out you can live with. so they did a stimulus with him rather than saying the economy slipped for us. in 2008 we do that t.a.r.p. together. bipartisanship in america ended in january 20, 2009, with mitch mcconnell say now my new job
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is to sit the president. even then we had a constructive two years. the breakdown is fairly recent and it's because the tea party, the extreme right took over the republican party, intimidated people that i'm optimistic for two reasons. first i think reality will be better. i think you'll see the health care bill provided benefits, financial reform bill provides stability in the sun will still go up in downtown new york in the morning and there still be very, very rich and have her money than anybody needs. but then there's the question, how will the republican party react? there's still a pretty people who say let's be conservative, but let's back up on some of this anti-immigration status and even let's talk about the good of our revenue for the subtle government. so i say with is getting better, less anger fuels both occupying
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tea party is a very good chance of it back to legitimate competition between the parties, the kind before 2010. >> let's leave it there on a hopeful note. barney frank, everybody. thank you very much. [applause]
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>> now, more from the washington ideas for them. next, senator amy klobuchar for minnesota on women in the senate. the museum, this is a 15 minute
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period >> next, we have katty kay at the bbc interviewing amy klobuchar who just killed in this election. she won in minnesota by 35 points. people are saying she owns the state lake hubert humphrey and is better looking. [applause] ..
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>> with the statue of strom thurmond. [laughter] whenever it did said in a room stays in the room. we never talk about the male senators. [laughter] but the group has worked well together sometimes on
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legislation or women's health, of burbank, but mostly before to the relationships. my first bill was with olympia snowe. a number of women are problem solvers that you have seen this in the election. but they saw her someone to compromise and there we're elected officials who had the quote that was accurate that said riven politicians speak softly and carry a big statistic. maybe not anymore but there is a model with men coming elected officials who had the quote that was accurate that said riven politicians speak softly and carry a big statistic. maybe not anymore but there is a model with men coming against all odds hoping for about -- more
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accountability. level look at the records of janet napolitano from their stated shows their goals and what they got done. even some of the male senators as well. the balance of power stayed the same but there was a rejection of people who had ridge did ideologies. they don't want people swinging at the tethers from the opposite corners. >> host: we do see it in business we are good at cooperating and more risk averse. is that your experience with politics? laraque been in the audience but doesn't matter to them? >> many have daughters and they think it is great to see women as role models.
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a different spirit. despite the image of congress and the senate was moving things the farm bill, the reform bill, six bills that were done marching through multiple amendments. with the percentage of women, 17, barbara boxer against all odds worked out a deal with jim inhoffe and got the transportation bill done. susan collins was sitting over and debbie stabenow with the heroic effort on the farm bill. it is not just talk and rhetoric. we help each other across the aisle.
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>> i have seen women propose more bills and are able to keep alive more than the counterparts. >> this election wanted action. do think the public will be rewarded and get more done? willow this be able to get more done? >> there isn't a choice. anyone who has looked to the election knows that is what people want. the country cannot stand still. we have to bring down the debt to and i think the electorate voted while the but we need to do positive things for the economy to make sure the workers are getting what they need at with engineering and wrap up the high-school level.
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and with this election 10% are hispanic and 75% voting for the president and many rebook-- republicans are talking about moving on and immigration reform. some things can move the economy if we can compromise on the debt to the knife the comprehensive energy policy so i am much more optimistic. you mention hubert humphrey and i have my doubts. >> the president has just given a press conference sounding feisty on the issue of taxes. he seemed to be saying he was given a mandate by the
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american people not to continue with tax cuts. with mitt romney in this campaign will that hold up with the budget negotiations? >> i want to bring the debt down. people making over to reduce $50,000 per year would be taxed at the bush level then at the clinton level it saves about $700 billion. that is why we're so interested in that proposal. i see it is the way to bring
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in the money. one way is spending cuts and it has to be a shared sacrifice. if it was a small amount of money or just about the election it brings of big chunk of change to bring fed that down with the subsidies that can be cut. i believe the biofuels and those breaks have gone away. oil is $40 billion. we are proud of the oil drilling with the natural gas extraction we still need the subsidy. together that is
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$100 billion in 10 years. there is a rational reason we should talk about these things. how do we bring down the debt over 10 years without a sharp contraction in this out the political support? we are it is the money to bring it down to make our akon and remove for word. >> what did bill clinton say? arithmetic. i like that moment that he was pointing out what numbers added up but to the democrats were chanting arithmetic.
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did just cannot be sound bites. those were real bills that passed. 62/75 boats -- boats. we got it done. on some of those bills after we got it done there was pressure on the house and the group of us supportive of the debt commission report we may not agree with everything but depending on the day 40 are 55 senators meeting off and on to push them through. >> there is a devotion. paul ryan said it is not their intention to raise tax rates. didn't want to agree to the tax hikes how will you work
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with republicans in the house? this is not what we will negotiate? there has been some change there and speaker boehner but up the olive branch that is the debt negotiations are all about. but look at the tax-cut issue as a major part of the solution and add that into other deductions it is a chunk of change. >> with the press conference . >> guest: i missed the meeting but they passed their blackberry around. he is clearly showing flexibility but the republicans also have to.
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>> host: you think by the end of the year will sort it out? you are confident? >> we will have to sort out part of it. fifth not every t in every i will be dotted. the estate tax issue where they are now with exemptions. the number of things that should get done and others could be extended there is m&a. the comprehensive tax reform is the hope to bring the business tax rate down with a loopholes to get rid of the subsidies. many were second per-capita in my state from the pace maker to the post and no.
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they want to see the business tax rate down and willing to talk about loopholes but that is a major debate that cannot be concluded by the end of the year. that aston be the next thing that we tackle. >> the election is watched avid the. whether america 10 needs to do big things to stay competitive. will you divide the financial market? >> when center joe? tried everything? there you go. you have seen that over the last decade. it is frustrating but whether the tarbell and then
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the fiscal cliff when the economy started to sink we could get our act to gather. what i want more is to seize the opportunity where we make stuff in america again. that is the way to truly crawl out. we're now down and 5.8% unemployment dealing with high tech manufacturing and the export base to have the educated work force. if you look at the model and other midwestern states, it is some model. working with export promotion that is our focus which is also tourism. we lost 60% of the
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international market with 9/11 because we did not to our math with the be separate of that is 160,000 jobs. europe could process those faster so few and shanghai it took 10 days but it would take 90 days to go to america we have now improve that. that is the tip of the iceberg h-1b visas and we already have a senator senator rubio, senator mikulski and others said a willing to step out on the visa issue that should extend into immigration reform. >> you mention and the risk
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of losing democrats in the senate. they will be tough. so what was it you like they you are prepared to compromise? >> a number of democrats did not want to see what we saw. we are ready had 1 trillion and and then this sequestration another 1.2 trillion. these are automatic cuts for darfur for the renegotiate but if you do this we will have to make cuts. that is the number one that we need to a knowledge that their word democrats that did not go for that.
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seven of you have those that go for that then and the liberal democratic congressmen the against it and michelle balk. [laughter] you will see some of that where some of the bills have been more republican and or the house not voting now you have democrats. it is even more important that the republicans work with us and we have enough members to get it through the senate and house. >> host: thank you very much. hopefully you can do something. [applause]
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>> i can the in this hearing of the subcommittee to examine the recent outbreak of fungal meningitis linked to contaminated products made by been doing good compounding center. of one to extend my deepest -- deepest condolences for anyone that has lost a loved one and the
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tragedy. 32 people have died including three with in my congressional district marion county, one lives write-up the street from the. 400 people have been sick and making this one of the worst public health disasters ever caused by a contaminated drug company in this country. after a tragedy like this we ask could this have been prevented? after examination the documents produced by the massachusetts board of pharmacy and the fda the answer appears to be yes. before the outbreak fda conducted three serious of inspections of new england, pounding center or an bcc -- necc. and it is even more extensive involving 12
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separate complaints of the mbp for its pharmacist since it opened 1998. over the course of the inspections, regulators noted the same kinds of problems at issue was sterility, violation of its own license. out in 2002 adverse events were reported with patients that had received steroid injections made by necc. the fda followed up. six months later patients were hospitalized after receiving necc injections. in one case to be seen as a simple warning come in 2002 they had meningitis like symptoms.
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the product in question was the same product connected to the current outbreak. necc was contaminated with bacteria. after those cases officials from the fda and medical pharmacy board met for the conduct and made a prophetic statement the potential for serious public health consequences if necc compound dean practices relating to sterile products are not improved" end quote. even though they were aware of the risks posed by their practices, they were simply slow to act. took 584 years finding
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problems with the sterility practices with the food drug and cosmetic act to issue a simple warning letter. the company challenged the charges. it took fda another two years to respond to the company's claim when they finally did respond six years later it director the company to correct the violation and warned it would follow up with future inspections but they never did. night even after the colorado board pharmacy notified the agency necc was sending drugs to out of state hospitals without first receiving prescriptions and the fda did not refer them to the massachusetts board for follow-up.
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what would have happened if 58 investigated door informed of the massachusetts board of the break this could have been prevented. we are july and by a joyce lovelace whose has been passed away in september. we thank you for sharing your story with us today. i pledge we will get to the bottom of this so we can ensure this outbreak can never occur again. we're also joined by to boost -- commissioner margaret hamburg and the commissioner public health. where they think this could have been prevented in the agencies did enough they have a long history of bipartisan oversight and
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this is no exception of. and to determine the reasons why such a of a history. know i will defer the remainder of my time. >> i think it is expired. >> then we will go to the ranking member. >> four minutes. thank you very much. i appreciate you taking the time on the day that we've returned because this is a public health issue. the contaminated stair raid injections by necc have cause 438 cases of fungal meningitis from 19 states. 32 people have died and the
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number could climb. we have four witnesses today. i am eager to hear from the fda and massachusetts board of pharmacy comment mbp that had the primary regulatory authority how we got here. and how i unearth his company could have been so irresponsible to cause the death of so many americans. also joyce lovelace is the wife of one of the first victims and iowa into express my deep sadness and i want to thank you today. congressmen nano it is hard but it is important. it reveals failures on multiple levels and there is
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a lot of blame to go around. mr. barry cadden failed to ensure they were following appropriate safety rules and guidelines. again and again problems were brought to the attention of the massachusetts board of pharmacy and it failed to act. 1999 through 2002, a 2003, 2004 and the past summer but necc keeps a license to avoid penalties and continue operations until tragedy struck. we need to hear an explanation from the fda inspectors and officials were repeatedly informed of problems but the strongest action taken was a warning
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letter sent to the company 2006 that have little effect. they tell us there we're hobbled by questions if they have the legal authority to address the questions of this is true this is a problem that demands full attention. we need to clarify the food drug and cosmetics act that limits jurisdiction over compounding pharmacies to make sure for the large pharmacies they have the ability to act and act quickly. of 30 people have died because too many signals were mixed. but they came from my home state. the the favor distributing unlicensed and unregistered
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drugs it issued cease-and-desist order. and not enough but the colorado board did the right thing but this list of vyyo. the fda did not act. massachusetts did not act for crum mr. chairman, but for those drugs that we rely on come with the gentleman mixing prescriptions for the little child, unfortunately it makes it clear that large corporate, pounding pharmacies are operating not checked as american families trust their lives. we need to work together to make sure this is not
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repeated and i will yield the rest of my time. >> thank you. dealing with the compounding center that is in my district in framingham and my condolences go to their families. it is part of the subject of complaints of 1999, a 2001, a 2002. necc under barry cadden was appointed to the state task force in june 2006 the state board weighed sanctions. my report which i have completed on the issue shows 23 deaths in 2218 -- jeremy cohen, i want to i will not
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stop until we make sure these industries are safe. we need to make sure this never. >> good gentleman from michigan. >> when we first began the investigation we knew people were sick but one grandmother from cass county lost to life because of the contaminated drugs. what makes this worse is the fact that they could have been prevented. necc was not unknown but operating tender the shadow of darkness. a 30 minute drive from the fda district office and them
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and any state regulator had inspected the facilities and number of times since the company it open their doors and issued a warning letter and then entering into the consent suck to learn of this section over 10 years ago identified contamination in the very same drug of the outbreak. the reason is patients have been hospitalized. 10 years later the of by the cannot have fallen ill prepared to say we would hear from the the primitive health and why they treated the company why they did.
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why did federal regulators feel confident this company could make drug safely after repeated the finding they were contaminated? after serving multiple violations leading up to the warning letter come out why did the agency failed to conduct a single follow up? as you try to uncover the facts to ensure this never happens again. 32 innocent americans have died and the public deserves to know what robert go and the board as provided thousands of documents. thank you for year staff to be available and with a have not provided the key timeline information from
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years ago. fda needs to focus on the we will insist on a firm timetable purpose sooner they cooperate we can determine in what went wrong and what we need to do to fix it so it doesn't happen again. our hearts are with you. we appreciate your testimony during this tough time. i yield the balance of my time. >> you heard the saying you can bring a horse to water but you cannot make it drink you could take a regulator to our problem but it will not regulate. we have numerous cases of the last 15 years of state and federal regulators being
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made aware of problems and they go out and investigate or ask for documentation then issue a general reprimand or nothing at all. it is an absolute tragedy that 32 people have died and it is unlikely that is the end of the death toll. we have to get the regulatory of gordy at the state and local level. with a bad actor you have to use the regulators to use the authority given to them to stop these practices. if you read the reports, the repeated instances of where inspectors could see obviously contamination and the various batches of this
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product and going on between 10 the rise of disaster capitalism" years. i want to thank the ranking member and committee member to immediately call for a hearing asking the saxby may present and let's find out what the facts are then find out what is necessary to put a stop to this once and for all. >> recognized said gentlemen from california. >> thank you for holding the hearing and making this bipartisan. this is an ongoing public health tragedy. necc shipped 17,000 files of the steroid and told members
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were contaminated with the fungus that have killed 32 people and 438 have gotten sick with the tragedy that has brought on unspeakable devastation. so today takes courage. >> rehab learned the facts are troubling. let's not lose sight of the wrongdoer as we blame the regulators. we had the former president to be here to testify about how the company handled the matter.
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what we learned, even 10 years ago through new there could be a meningitis outbreak? it was not corrected by the company. it went about its way to tell people they would be paid better and change their ways. that does not mean we don't on regulators but it is clear the mhusetts board of registration and pharmacy and other state providers identify and after
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the outbreak but for them to allow this to happen, the massachusetts board has primary jurisdiction, misstate to regulate the company and they were informed of problems and even did theron investigation but the board never took action tough enough to stop necc from putting consumers at risk. the fda was informed of the problem coming conducted investigations a and raised concern some of that previous attempts to review
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the actions weren't met with stubborn refusal senate challenge to the fda authority. congress acted specifically to limit the authority of the fda and the supreme court case listed what authority it had left. this tragedy took action from this congress. mr. markey has a good bill for a start that we could pass with bipartisan legislation to preserve the compounding facility to operate safely to give the clear one of the most dangerous. >> the gentleman from michigan is recognized.
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with the consent you could have been additional two minutes if we have two speakers that one knitted a peace. >> thank you. >> the distinguish chairman of the full committee under their maturity recognized for three minute. >> i commend you for holding the hearing. i am pleased to speak but i note to my home state of michigan has 129 but did this survey answers have could this so for.
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but with the issues and significant other problems to not the reagan luis to sit on the border of the two authorities they could disregard their responsibilities to the best to lebed situation 10. 212 chose not to address the deficiencies with the massachusetts board of pharmacy and compounding steroids about a specific prescription as three acquired by massachusetts but i am concerned 5012
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operated at a volume that they could not be considered traditional compounding pharmacy but properly as a drug manufacturer. warnings were erred given on medications to all concerned and we have to see that situation is not obtained again. we have us is done before us what belongs to everybody appears to belong to no one and as a result neither agency responsible but with the problems. this committee intends to work with us together to find out but what would be
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needed to prevent future outbreaks from the one we are now suffering, i am convinced this will require fairly strong legislation but i thank you for your courtesy and a yield back the balance of my time. >> now recognize the gentleman from virginia. >> thank you for holding this hearing like others my area in virginia has been hard hit with two fatalities and iowa's on the phone this morning with the father of the youngest it down to date of the man who just turned 16. he has a advantage of age but they do not know the end
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result. the friday before he caught three interceptions and ran back one for a touchdown. but how well his life be changed? we don't know. our job is to find out why and that it doesn't happen in again. of the accord to working with everyone in a bipartisan fashion and also this joyce lovelace to be here. we're sorry for your loss. >> the gentlelady from tennessee. >> i am appreciative of the work you and your staff have done and moving forward quickly. we are appreciative ms. joyce lovelace could join us. according to the cdc 81
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tennesseans have been affected with fungal meningitis. this is of tremendous concern and because of this and those families adversely impacted i am interested to hear why the fda did not pursue enforcement actions despite emphasizing one decade ago, nearly one decade, the potential for serious health problems. these are the answers we are looking for and i yield back. >> we're now ready to have our first panel mrs. joyce
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lovelace and the wife of the late honorable lovelace. serving as a circuit judge for the 40th district and was the first confirmed death as a result of begins she begins heard testimony on lake to loathsome the 10 to amend that represents the first but also ranking members wheat appreciate you being here to investigate this issue. i feel fortunate to be with her today as the constituent because ever since i have
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been a member of congress they have been good friends of mine and living in all but a kentucky. if you look at the individual life it makes a difference. married almost 56 years, i he died september 17, from complications from the steroid injection causing fungal meningitis which is the focus of the hearing. he was 78 but most people thought he was 50 because the walked for miles everyday and a judge and also as a chief prosecutor for the county attorney and was involved in every aspect. we will all miss eddy and
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never forget him but i want to thank joyce for sharing their story with the committee. >> thank you for the introduction. you are aware the committee is holding in investigative hearing. in doing so we take testimony under oath. could you have been the objection? so under the rules of the house and the rules of the committee you are entitled to be advised by your counsel. do you would buy it -- keira to be a vice today? [inaudible] if you are able to stand if not please raise your right hand. do you swear to tell whole truth and nothing but the truth so help you god? >> baidu i do title 186101 o
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o one of the united states code we welcome you today now you can give your five minute summary. >> bank to mr. chairman and members of the committee. i am encouraged by what i have heard today that you plan to investigate this matter that what my family and die desire to get to the bottom of this because we have lived a nightmare and will be ages to come. we will never be able to get closure because it is a useless thing that have been
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to. i aid don't have any notes. my husband hated notes. i am here on unhinge is behalf. i am speaking from a heart. he would not want me to have notes. he never read. he always spoke. i was fortunate enough to be married to this man. it was not always plus said doris mou but we've worked together. we were married when he was in law school. we made our home there and he got involved with civic matters and was still
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teaching when he passed away. a gifted speaker. i just want these people to know the kind of person that has perished because of their lack of concern. my family is bitter. a great. heartbroken, devastated. i come here begging you to do something about the matter. i cannot say enough good about him. he was bigger than life. i worked in his office with him and i have seen him interact in all situations
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with all people. he had a gift of working with people and was compassionate. he wanted to help the people that needed it. he'll is wanted the victim to be taken care of. it is ironic he was a victim. i cannot begin to tell you what i have lost. my soul mate, my partner. words cannot describe. children, grandchildren from a he was there a cure, there rock, they looked to him.
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he helped the older ones through college and what direction they wanted to take. the oldest granddaughter became an attorney based on her appreciation for him and the work that he did. he had two more years left in his term and then help our granddaughter get started with her practice. now she has no one. the and your grandchildren have lost the best playmate they ever had. they could dress him up for do anything. he was happy to do it.
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the angus granddaughter asked with gas prices so high to drive me around and let me read? he would drive in the card to let her read her books. these are the things that we will mess. he studied the law every weekend on friday he wanted all of the opinions of the appellate courts printed out and that was the weekend reading. he would get mad if we did not get it done. that would ruin his weekend. he was not sick.
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he was healthy joaquin 3 miles before a wicked out of bet. -- before i would get out of bet. he wanted to stay active he did not have the appearance of a 78 year-old man until the second injection. he walked the streets every morning he was losing his balance and he felt often. he began to have headaches and i was concerned he looked of someone that might have cancer. he had a physical examination two weeks before he became sick.
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the only problem was allergies. on september 11 he had some numbness in his hand and we begged him to go to the emergency room and he declined. that evening he had a bad headache and said the two fingers on his hand or not right. then it was his fist but he would not go to the emergency room. he just would not go to the doctor. and next morning, when i got
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up he was then that kitchen with a horrible book on his face. he said my legs don't work. i have been out twice to get the paper and i have fallen twice. i called my daughter who took him to the emergency room. i believe they did the ct scan but it did not show symptoms. they transferred him to vanderbilt. he did have a car accident in last march and injured his lumbar and cervical spine. he had done everything he was told to do to get back on the job.
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he was transferred and where he received these injections. at the st. thomas narrow surgical outpatient center. within one day he started to decline. rapidly. the speech became slurred, no group in his left hand your left foot. he had no i hand coordination. it was a nightmare to see this man who was perfectly